Kornimate/medical-research-clean huggingface dataset:
autologous bone marrow mononuclear cell transplantation in treating type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 diabetes mellitus. we hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted bmmcs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

to study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. according to the intervention and baseline characteristics, patients are divided into 4 arms.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * age 30-70 * stable doses of medication for at least 3 months * bmi \ 18.5 exclusion criteria: * secondary cause for hyperglycemia * pregnancy or nursing * positive autoimmune antibody of diabetes * severe complication or concurrent diseases * active infection or febrile illness * allergy to iodine * history or signs of aortic aneurysm * history or active pancreatic diseases * known substance abuse or alcoholism or heavy smoking * not suitable for other conditions upon investigators' expertise

Keywords: type 2; diabetes mellitus; stem cell; safety; efficacy
comparison of breast pump suction patterns

Conditions: Insufficient Breast Milk Syndrome

Summary: compare effectiveness of breast pump patterns on lactation outcomes of pump dependent mothers of critically ill infants

insufficient mothers own milk (mom) has its origins during the first 14 days postpartum, a critical window that includes secretory activation (sa; milk coming in; lactogenesis ii) and the achievement of coming to volume (ctv; providing 500 mls/day of mom by day 14 postpartum). for all lactating mothers, sa must be achieved for lactation to continue, and ctv predicts provision of mom through to neonatal intensive care unit (nicu) discharge in preterm very low birth weight (vlbw; \<1500 g birth weight) infants. for this study, we posit that alternate breast pump suction patterns (bpsp; suction rate, intensity, and rhythm) may facilitate achievement of ctv in mothers who have achieved sa, but whose daily pumped mom volumes indicate a high risk of not achieving ctv. therefore, the overall objective of this study is to compare the clinical effectiveness of three different breast pump suction patterns on lactation outcomes, including achievement of sa, among pump dependent mothers of critically ill infants who demonstrate faltering lactation after achievement of sa. at 6-8 days postpartum, 90 pump dependent mothers of critically ill infants who have achieved sa but demonstrate faltering lactation (\<350 mls/day pumped mom volume), will be randomized to use one of three different bpsps with two groups having alternative bpsps and one group using the current practice standard for 7 days.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * delivered an infant admitted to the nicu * intent to provide exclusive mother's own milk to their infants for the first 14 days postpartum * expect to be breast pump dependent for the first 14 days postpartum exclusion criteria: * breast reduction or augmentation * infant not expected to survive * medications or maternal conditions incompatible with providing mother's own milk to a nicu infant * resides over 60 miles from university of florida (ufhealth) in gainesville, fl.
somatropin treatment to final height in turner syndrome

Conditions: Turner Syndrome

Summary: a randomized, controlled trial in girls with turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of humatrope (somatropin) treatment in promoting linear growth to final height.

a randomized, controlled trial of humatrope (somatropin) treatment in girls with turner syndrome at least 7 years old and younger than 13 at study entry. core study objectives are to determine the efficacy of humatrope in promoting linear growth to final height in girls with turner syndrome, and to assess the safety of this treatment. core study completion criteria (protocol final height) are that the patient has both a height velocity \< 2 cm per year and a bone age of 14 years or greater. addendum 1 provides the option of humatrope treatment to patients who were randomized to the control arm of the core study and who discontinued from the study on or after december 19, 1997. addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing, tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in turner syndrome; 3) to evaluate pancreatic beta cell function (glucose metabolism) in patients previously enrolled in the core study. addendum 3 objective is to determine the parental origin of the retained x chromosome of an appropriate subset of patients currently or previously enrolled in the core study, and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy.

Eligibility criteria:
inclusion criteria: * girl with turner syndrome * prepubertal, tanner stage i breast * height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population * at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity * if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests exclusion criteria: * prior treatment with growth hormone * presence of a y component in karyotype with gonads in situ * diabetes mellitus

Keywords: syndrome turner turner's height growth growth hormone somatropin short stature short hearing glucose metabolism
precise high resolution mri to increase accuracy and gain confidence to diagnose patients with optic disc edema

Conditions: Optic Disk; Magnetic Resonance Imaging

Summary: the presence of optic disc swelling at the fundus is a non-specific clinical sign that can occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. the diagnostic range is vast, including inflammatory pathologies of the optic nerve, infiltrative or compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to mention the pseudo optic disc swelling found in drüsens. mri is increasingly being used as a first-line examination to obtain an etiologic diagnosis in a patient with optic disc swelling. it allows a rapid diagnosis to be made in cases of inflammatory pathology or compressive or infiltrative pathology. it can provide very suggestive elements in the case of intracranial hypertension. it appears to be potentially useful in diagnosing ischemic optic neuropathy or in directing towards an etiological diagnosis of giant cell arteritis. the development of new high-resolution mri sequences has made it possible to obtain extremely fine resolutions of a few hundred microns in the plane. apart from a few clinical cases and small series, there is no precise evaluation of the interest of these new sequences in the positive and etiological diagnosis of ophthalmological, neuro-ophthalmological and encephalic pathologies responsible for the presence of optic disc swelling. the objective of our study is therefore to evaluate the diagnostic contribution and the gain in diagnostic confidence provided by these new sequences in the context of pathologies manifesting as optic disc swelling.


Eligibility criteria:
inclusion criteria: * patient over 18 years old * presenting a papillary edema detected clinically at the back of the eye * express consent to participate in the study * affiliate or beneficiary of a social security scheme exclusion criteria: * mri contraindication (electrical device, metallic foreign body, claustrophobia) * patient benefiting from a legal protection measure * pregnant or breastfeeding woman
prevention of surgical site infections

Conditions: Surgical Wound Infection

Summary: the primary research question is whether interventions to prevent caregiver and system errors will increase the proportion of laparotomy patients who receive recommended measures to prevent surgical site infections.

background: surgical site infections (ssis) cause significant and largely preventable morbidity, mortality, and resource use due to failure to comply with evidence-based guidelines. quality improvement programs report increased compliance with these guidelines, but are subject to a variety of biases. hypothesis: the primary hypothesis is that a targeted intervention program will increase the proportion of patients in a county hospital who receive recommended interventions to prevent ssis, when assessed in the most rigorous feasible clinical trial. the specific aims of the trial are to establish practical surveillance measures to determine the percentage of patients whose care complies with 5 major guidelines to prevent ssis; to use chart review, direct observation, attitude surveys, and focus groups to identify, quantify, and address latent and active errors linked to non-compliance, and to develop, implement, and assess the effectiveness of an intervention program to increase guideline compliance. study design: an innovative trial design will be performed with 3 staggered phases in the two major county hospitals in houston, tx. this design allows for adjustment for temporal trends and hospital differences in assessing the intervention program in a large, high-risk, disadvantaged urban population. based on a compliance goal of 95%, this design has adequate power to detect even a small absolute increase ( \>= 5%) above baseline in the percentage of patients receiving all 5 recommended preventive measures.

Eligibility criteria:
inclusion criteria: * all patients undergoing laparotomy at either ben taub hospital or lyndon baines johnson hospital in houston, texas exclusion criteria: * none

Keywords: antibiotic prophylaxis
su5416 in treating patients with refractory or relapsed multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: su5416 may stop the growth of multiple myeloma by stopping blood flow to the cancer cells. purpose: phase ii trial to study the effectiveness of su5416 in treating patients who have refractory or relapsed multiple myeloma.

objectives: i. determine the response rate and response duration of patients with refractory or relapsed multiple myeloma treated with su5416. ii. determine the toxicity of su5416 in this patient population. outline: this is a multicenter study. patients receive su5416 iv over 1 hour twice weekly. treatment continues in the absence of unacceptable toxicity or disease progression. patients are followed for survival. projected accrual: a total of 20-38 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: histologically confirmed multiple myeloma with an elevated monoclonal protein in serum and/or urine no history of cns lesion or cns bleed patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: cytopenias secondary to multiple myeloma involvement of bone marrow allowed cytopenias not due to multiple myeloma require: wbc at least 3,000/mm3 platelet count at least 75,000/mm3 hepatic: transaminases no greater than 2 times upper limit of normal bilirubin no greater than 1.5 mg/dl renal: creatinine no greater than 2.0 mg/dl or creatinine clearance at least 50 ml/min cardiovascular: no congestive heart failure, severe peripheral vascular disease, or significant arrhythmia no poorly controlled systolic or diastolic hypertension no uncompensated coronary artery disease no history of myocardial infarction or severe/unstable angina within past 6 months no known hypercoagulable state or deep venous or arterial thrombosis within past 3 months pulmonary: no pulmonary embolism within past 3 months other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception during and for 3 months after study no other severe medical or psychiatric condition (e.g., active peptic ulcer, active infection, or history of severe alcohol or drug abuse) no known hypersensitivity to paclitaxel or cremophor prior concurrent therapy: biologic therapy: see chemotherapy chemotherapy: at least 1 but no more than 3 prior chemotherapy regimens induction followed by high dose therapy with stem cell support considered a single treatment regimen tandem courses of high dose therapy considered as 2 regimens endocrine therapy: at least 1 prior regimen containing steroids radiotherapy: prior radiotherapy for symptom control allowed surgery: at least 3 weeks since prior major surgery at least 1 year since prior coronary artery surgery, angioplasty, or stent placement no prior brain surgery other: no other concurrent investigational drugs concurrent bisphosphonates (e.g., pamidronate) allowed

Keywords: refractory multiple myeloma
second line breast cancer trial

Conditions: Advanced Breast Cancer

Summary: the main purpose of this study is to compare the effect of 2 doses of faslodex with 1 dose of arimidex in terms of time to tumor progression in postmenopausal women with advanced breast cancer.


Eligibility criteria:
inclusion criteria: * postmenopausal women with confirmation of breast cancer * objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer exclusion criteria: * presence of life-threatening metastatic visceral disease * previous treatment with faslodex, arimidex or any aromatase inhibitor for breast cancer * more than 1 prior endocrine medical treatment for advanced breast cancer .

Keywords: advanced breast cancer, faslodex, arimidex, fulvestrant, anastrozole, postmenopausal
a study to characterize the pk and pd profile of iv fcm in pediatric subjects 1-17 years old with ida

Conditions: Iron Deficiency Anemia (IDA)

Summary: this is a phase ii, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (pk/pd) profile of ferric carboxymaltose dosing in pediatric subjects with ida after receiving either a 7.5 mg/kg or 15 mg/kg dose of ferric carboxymaltose.

this is a phase ii, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (pk/pd) profile of ferric carboxymaltose dosing in pediatric subjects with ida after receiving either a 7.5 mg/kg or 15 mg/kg dose of ferric carboxymaltose.

Eligibility criteria:
inclusion criteria: * male or female subjects 1 to 17 years of age with assent to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the independent review board / ethics committee. * screening tsat \< 20% * screening hemoglobin \< 11 g/dl * for subjects who are receiving an erythropoietin stimulating agent (esa): stable esa therapy (+/- 20% of current dose) for \> 8 weeks prior to the qualifying screening visit and no esa dosing or product changes anticipated for the length of the trial exclusion criteria: * known hypersensitivity reaction to any component of ferric carboxymaltose. * subject previously randomized and treated in this study or any other clinical study of ferric carboxymaltose (fcm or vit-45). * body mass index (bmi) ≤ 5th percentile for age (see appendix 2) * male or female subject 1 year of age weighing \< 12kg. * history of acquired iron overload, hemochromatosis or other iron accumulation disorders. * chronic kidney disease subjects on hemodialysis. * screening ferritin level \> 300ng/ml * subjects with significant severe diseases of the liver, hemopoietic system, cardiovascular system, psychiatric disorder or other conditions which on the opinion of the investigator may place a subject at added risk. * any active infection. * known positive hepatitis b antigen (hbsag) or hepatitis c viral antibody (hcv) with evidence of active hepatitis. * known positive hiv-1/hiv-2 antibodies (anti-hiv). * anemia due to reasons other than iron deficiency (i.e. hemoglobinopathy). subjects treated with vitamin b12 or folic acid deficiency are permitted. * intravenous iron and /or blood transfusion in the 4 weeks prior to screening. * immunosuppressive therapy that may lead to anemia (i.e. cyclophosphamide, azathioprine, mycophenolate mofetil). note steroid therapy is permitted. * administration and / or use of an investigational product (drug or device) within 30 days of screening. * alcohol or drug abuse within the past six months. * female subjects who are pregnant or lactating, or sexually active female who are of childbearing potential not willing to use an acceptable form of contraceptive precautions during the study. * subject is unable to comply with study assessments.
krill oil and resistance exercise in older adults

Conditions: Sarcopenia

Summary: the aim of this study is to determine whether krill oil supplementation enhances effects of a pragmatic resistance exercise programme on adaptations in muscle strength, mass, function and neuromuscular function in sedentary older adults. hypothesis - krill oil supplementation will enhance the beneficial effects of resistance exercise on muscle strength, function, mass and neuromuscular function in sedentary older adults.


Eligibility criteria:
inclusion criteria: * over the age of 60 years * scoring a low level of physical activity based on international physical activity questionnaire (not meeting the recommend physical activity which is at least 600 met-min per week). exclusion criteria: * diabetes * severe cardiovascular disease * seizure disorders * uncontrolled hypertension (\>150/90mmhg at baseline measurement) * cancer or cancer that has been in remission \<5 years * ambulatory impairments which would limit ability to perform assessments of muscle function * dementia * taking medication known to affect muscle (e.g. steroids) * have an implanted electronic device (e.g. pacemaker/defibrillator/insulin pump) * on anticoagulant therapy * allergies to seafood * regular consumption of more than 1 portion of oily fish per week * already taking fish or krill oil or other n3 pufa supplements * femoral neck fracture or other severe of hip or knee operations * stroke * parkinson's disease * copd * kidney disease * hyperlipidaemia * obesity * osteoporosis.

Keywords: home exercise resistance exercise exercise krill oil muscle strength neuromuscular function physical function
iv cocaine abuse: a laboratory model - 2

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.


Eligibility criteria:
please contact site for information.

Keywords: intravenous abuse
hand jing-well points stimulation to treat disorders of consciousness

Conditions: Disorders of Consciousness Due to Severe Brain Injury

Summary: the purpose of this academic lead study is to explore the ideal stimulation strategies at hand twelve jing-well points in patients with disorders of consciousness.


Eligibility criteria:
inclusion criteria: * age: 18-80 years old * from 7 to 90 days since brain injury * diagnosed in vs/uws or mcs as deﬁned by at least two crs-r assessments performed during the screening period * acquired cerebral damage of known etiology * intact hand skin * informed consent given by the legal surrogate exclusion criteria: * patients who continuously receive sedative drugs and na+ or ca2+ channel blockers (e.g., carbamazepine) or nmda receptor antagonists (e.g., dextromethorphan) * history of previous serious、progressive neurological disorder prior to the brian injury * epilepsy and seizure * unstable vital signs or life-threatening comorbidities * active implant (e.g., cardiac pacemakers/defibrillators, deep brain stimulators, ventriculoperitoneal shunt, etc) * documented pregnancy
efficacy study of lisdexamfetamine to treat binge eating disorder

Conditions: Binge Eating Disorder

Summary: the specific aim of this study is to examine the efficacy and safety of lisdexamfetamine compared with placebo in outpatients with binge eating disorder


Eligibility criteria:
inclusion criteria: * patients will meet dsm-iv criteria for bed for at least the last 6 months exclusion criteria: * women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. if there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (all women of childbearing potential will have a negative pregnancy test before entering the study.) * subjects who are displaying clinically significant suicidality or homicidality. * a current or recent (within 6 months of the start of study medication) dsm-iv diagnosis of substance abuse or dependence
safety study of continued enzalutamide treatment in prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine if continued treatment with enzalutamide is effective in patients with metastatic prostate cancer.


Eligibility criteria:
inclusion criteria: * men with metastatic castration-resistant prostate cancer * progressive disease on androgen deprivation therapy * patients must agree to continue androgen deprivation therapy with a gnrh agonist/antagonist throughout the study or have had a prior bilateral orchiectomy * ecog performance score ≤ 1 * estimated life expectancy of ≥ 12 months exclusion criteria: * prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer * prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo) * history of brain metastasis, active leptomeningeal disease or seizure * severe cardiovascular or hepatic disease * pituitary or adrenal dysfunction